Expert Insights: Will the UK Relax Its Current Regulations for Cannabis-Based Product

Patrick Aiyes, MEng, Immunology Analyst, GlobalData, examines whether the UK is changing its perception on the role of cannabis-based treatments in clinical trials

Recently medicinal cannabis has been at the forefront of media attention in the U.K., and in July 2018 the U.K. home secretary announced that specialist doctors can legally prescribe cannabis-based products in the event of an exceptional clinical need.

This decision by the Home Office will place cannabidiol products into Schedule 2 of the Misuse of Drugs Regulations 2001, meaning it can be possessed lawfully by anyone who is given a prescription. Could this radical change in policy potentially cause the U.K. to further relax its regulations, especially if medicinal cannabis proves efficacious and safe in other clinical trials?

GW’s Epidiolex at the Center of Recent Policy Change

Prior to this change in regulation, cannabis-derived products belonged to Schedule 1 of the Misuse of Drugs Regulations 2001, which meant there was no therapeutic value associated with the drug, so it could not be lawfully possessed or prescribed and could only be used solely for research purposes. In 2013, Bayer’s Sativex, approved for muscle spasticity, and was reclassified as Schedule 4 part 1 under the Misuse of Drugs Regulations, meaning patients can lawfully possess the drug under prescription, though non-prescribed possession would be an offense. However, there were no more reviews into the policy for other cannabis-derived products.

The drug at the center of this recent radical policy change was GW Pharmaceuticals’ Epidiolex, which is indicated for Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), both of which are rare forms of epilepsy. In a Phase III double-blind controlled study for LGS, 42.2 percent of patients who were given Epidiolex had a 50 percent reduction in the number of seizures, compared with 23.5 percent of patients who were given placebo.

Medicinal Cannabis Demonstrates Good Efficacy and Safety Profile

Furthermore, there were no differences in the number of patients who suffered from status epilepticus between those given Epidiolex compared with those who were administered placebo, which gave assurance for the safety profile of the drug. Similar results were achieved with Epidiolex’s Phase III trial for DS. Key opinion leaders (KOLs) interviewed by GlobalData also expressed that Epidiolex has the potential to help at least 50 percent of epileptic patients and it will be safe and well-tolerated.

With the clear progression of policy change surrounding medicinal cannabis, the U.K. government may be starting to recognize that cannabis can create a health benefit for patients suffering from neurological disorders. There are currently eight ongoing studies taking place in the U.K. that look at cannabidiol’s efficacy across a range of disorders, such as multiple sclerosis, infantile spasm, and graft-versus-host disease. If medicinal cannabis continues to boast a good efficacy and safety profile in these studies, it could lead to the relaxation of regulations and soften the stigma surrounding the drug.